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Merck Sharp & Dohme (Australia) Pty Ltd

Regulatory activities for this sponsor.

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Cancellation by sponsor (139)
ARTG (79)
Prescription medicine registration (62)
Australian public assessment report (AusPar) (33)
Designation or determination (31)
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Sponsor content

352 result(s) found, displaying 111 to 120

DIFICID fidaxomicin 200 mg tablet blister pack Cancelled under Section 30(1)(c) of the Act

22 June 2022

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
EMEND aprepitant 80mg & 125mg tri-pack capsule blister pack Cancelled under Section 30(1)(c) of the Act

22 June 2022

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
EMEND aprepitant 125mg capsule blister pack Cancelled under Section 30(1)(c) of the Act

22 June 2022

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
KEYTRUDA pembrolizumab (rch) 50 mg powder for injection vial Cancelled under Section 30(1)(c) of the Act

16 June 2022

Cancellation by sponsor

Requested by Merck Sharp & Dohme (Australia) Pty Ltd
PROQUAD measles, mumps, rubella, varicella live virus vaccine injection vial with sterile diluent vial composite pack (337388)

12 August 2020

ARTG

Australian Register of Therapeutic Goods (ARTG) information for PROQUAD measles, mumps, rubella, varicella live virus vaccine injection vial with sterile diluent vial composite pack.
VARIVAX REFRIGERATED varicella virus vaccine live powder for injection vial with sterile diluent vial (337387)

30 July 2020

ARTG

Australian Register of Therapeutic Goods (ARTG) information for VARIVAX REFRIGERATED varicella virus vaccine live powder for injection vial with sterile diluent vial.
KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)

11 May 2022

Prescription medicine registration

Active ingredients: pembrolizumab.
KEYTRUDA (Merck Sharp & Dohme (Australia) Pty Ltd)

27 April 2022

Prescription medicine registration

Active ingredients: pembrolizumab.
Notice for belzutifan (Merck Sharp & Dohme (Australia) Pty Ltd)

2 February 2022

Designation or determination

Provisional determination
Notice for belzutifan (Merck Sharp & Dohme (Australia) Pty Ltd)

2 February 2022

Designation or determination

Orphan drug

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